AmerisourceBergen, a Pennsylvania-based company that provides drug distribution and related services, has agreed to pay $625M to settle an FCA case that claimed that a pre-filled syringe program at one of its subsidiaries violated several federal laws. The subsidiary, Medical Initiatives Inc. (MII), closed in 2014, but was responsible for moving cancer medications from glass vials to syringes. In September 2017, AmerisourceBergen paid $260M to settle criminal charges related to MII’s conduct. The company had previously set aside $575 to settle these allegations.
News of the settlement first broke with the company’s SEC filings. The wrongdoing stems from MII not being properly registered with the FDA and improperly opening sterile vials of oncology drugs, to pool the medicine, and transfer the medicine into single-dose syringes. Additionally, syringes were often shipped without a prescription, sometimes in doses exceeding plausible amounts of safe usage, and also sometimes to dead people. MII produced roughly 9M syringes with prefilled drugs, and only sought sterility testing on three occasions. When the results of the testing showed bacterial contamination, MII did not notify regulators or issue recalls. The violations allegedly occurred from 2005 to 2014.
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